TerminatedPhase 2

ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

Germany, Netherlands24 participantsStarted 2006-05

Plain-language summary

This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of concurrent panic disorder * At least 2 panic attacks within the 4 weeks before the screening visit * Naïve to the CO2 challenge test * Age 18-65 years (inclusive) * Ability to comply with all procedures mandated by the study protocol * Negative pregnancy test and adequate contraceptive measures Exclusion Criteria: * History of poly-pharmacotherapy for panic disorder or treatment resistance * Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia * History of abuse of benzodiazepines or tolerance to effects of benzodiazepine * Any concomitant psychotropic medication * Evidence of impaired hepatic, renal or cardiac functions * Participation in any drug trial in the preceding 6 months

What they're measuring

degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)

difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)

Trial details

NCT IDNCT00322803

Sponsorelbion AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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